Fear Isn't A Strategy: Rethinking AI In Clinical Trials

By Catherine Gregor, Chief Clinical Trial Officer, Florence Healthcare

Clinical research is entering a pivotal moment: the FDA is openly preparing for broader, responsible use of artificial intelligence, yet many organizations are moving in the opposite direction. A growing wave of “no‑AI” clauses in CDAs and CTAs is creating uncertainty for research teams and limiting even low‑risk tools designed to reduce administrative burden. At the same time, actual AI adoption in trial operations remains modest, leaving sites overwhelmed by manual processes that slow timelines and increase the risk of error.

This perspective challenges the industry’s reflexive caution and argues for a more balanced, risk‑based approach — one that mirrors the FDA’s own guidance. By focusing on intended use, validation, human oversight, and proportional controls, clinical research can embrace AI in ways that strengthen safety while reducing time waste, one of the most overlooked contributors to patient harm.

Readers will gain clarity on what regulators are truly signaling, where contractual barriers are emerging, and how sites and sponsors can advocate for modernization that supports — not constrains — quality. Explore why inefficiency is the real threat to trial integrity and what it will take to move forward responsibly.